Recall Z-1171-2016— Sekisui Diagnostics P.E.I. Inc.
Class II · Terminated
Class II FDA medical device recall by Sekisui Diagnostics P.E.I. Inc., initiated 2016-01-22, terminated 2016-08-09. It names one FDA 510(k) clearance: K081938. Product: Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.. Reason: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover.
- Recalling firm
- Sekisui Diagnostics P.E.I. Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-22
- Terminated
- 2016-08-09
- Firm location
- Charlottetown, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Reason for recall
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Data sourced from openFDA. This site is unofficial and independent of the FDA.